CompletedPhase 1

A Clinical Trial of HEC93077 in Chinese Healthy Subjects and HUA Patients With Single or Multiple Dosing

China126 participantsStarted 2021-11-22

Plain-language summary

A phase 1 clinical trial of HEC93077,to evaluate the safety ,PK,PD and food effect in Chinese healthy subjects and HUA patients after single or multiple dosing.

Who can participate

Age range18 Years – 60 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Subjects who are willing and are able to provide a written informed consent to participate in the study.
✓. Subjects aged between 18 and 45 (both inclusive) years old.
✓. Healthy volunteers has a body weight ≥50 kg (for male) or ≥ 45kg (for female) and body mass index ≥19 and ≤28 kg/m2 at screening.
✓. Subjects, who are healthy, as having no clinically significant abnormalities in vital signs, physical examination, clinical laboratory test results, Chest X-ray and 12-lead electrocardiogram (ECG).
✓. Without Plan for pregnancy or pregnant within 3 months after enrollment throughout the trial.
✓. Serum uric acid≥240 and\<420 at screening.
✓. GFR≥90 mL/min/1.73 m2 at screening.

Exclusion criteria

✕. At screening subjects have the following diseases of clinical significance, including but not limited to cardiovascular system diseases, digestive system diseases, respiratory system diseases, urinary system diseases, endocrine and metabolic system diseases, blood system diseases, central nervous system and/or mental system diseases, immune system diseases, tumors, etc.
✕. A history of gastrointestinal, liver, or kidney disease or surgery prior to screening that could potentially affect the absorption, distribution, metabolism, and excretion of the test drug (except for uncomplicated appendectomy and hernia repair);
✕. History of urolithiasis or ultrasound screening showed urolithiasis, renal/ureteral malformation, unirenal or renal atrophy, polycystic kidney and other urological diseases
✕. History of gout and/or hyperuricemia
✕. Acute illness or concomitant use from signing the ICF to initial dosing.
✕. Known allergic reactions or hypersensitivity to any excipient of the drug formulation(s)， anaphylaxis physique.(Allergic to more than 3 foods and/or medications)
✕. History of alcoholism or drink regularly within 3 months prior to the study(defined as Alcohol consumption of \> 21 units/week), or positive results from alcohol breath test at screening.
✕. History of drug abuse, or use of drugs within 2 years prior to the study,or positive results from urine drug screen test at screening.

What they're measuring

the Number of Adverse Events (AEs)

Timeframe: up to 25 days

PK parameters - AUC0-∞

Timeframe: up to 18 days

PK parameters - Cmax

Timeframe: up to 18 days

PK parameters -tmax

Timeframe: up to 18 days

PK parameters -t½

Timeframe: up to 18 days

PK parameters -Vz/F

Timeframe: up to 18 days

PD parameters

Timeframe: up to 18 days

PK parameters - Ae0-t(urine)

Timeframe: up to 18 days

PK parameters - Ae0-t(feces)

Timeframe: up to 18 days

Trial details

NCT IDNCT05127772

SponsorSunshine Lake Pharma Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-10-31

View on ClinicalTrials.gov More Gout trials

Who can participate

Age range18 Years – 60 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Subjects who are willing and are able to provide a written informed consent to participate in the study.
✓. Subjects aged between 18 and 45 (both inclusive) years old.
✓. Healthy volunteers has a body weight ≥50 kg (for male) or ≥ 45kg (for female) and body mass index ≥19 and ≤28 kg/m2 at screening.
✓. Subjects, who are healthy, as having no clinically significant abnormalities in vital signs, physical examination, clinical laboratory test results, Chest X-ray and 12-lead electrocardiogram (ECG).
✓. Without Plan for pregnancy or pregnant within 3 months after enrollment throughout the trial.
✓. Serum uric acid≥240 and\<420 at screening.
✓. GFR≥90 mL/min/1.73 m2 at screening.

Exclusion criteria

✕. At screening subjects have the following diseases of clinical significance, including but not limited to cardiovascular system diseases, digestive system diseases, respiratory system diseases, urinary system diseases, endocrine and metabolic system diseases, blood system diseases, central nervous system and/or mental system diseases, immune system diseases, tumors, etc.
✕. A history of gastrointestinal, liver, or kidney disease or surgery prior to screening that could potentially affect the absorption, distribution, metabolism, and excretion of the test drug (except for uncomplicated appendectomy and hernia repair);
✕. History of urolithiasis or ultrasound screening showed urolithiasis, renal/ureteral malformation, unirenal or renal atrophy, polycystic kidney and other urological diseases
✕. History of gout and/or hyperuricemia
✕. Acute illness or concomitant use from signing the ICF to initial dosing.
✕. Known allergic reactions or hypersensitivity to any excipient of the drug formulation(s)， anaphylaxis physique.(Allergic to more than 3 foods and/or medications)
✕. History of alcoholism or drink regularly within 3 months prior to the study(defined as Alcohol consumption of \> 21 units/week), or positive results from alcohol breath test at screening.
✕. History of drug abuse, or use of drugs within 2 years prior to the study,or positive results from urine drug screen test at screening.

What they're measuring

the Number of Adverse Events (AEs)

Timeframe: up to 25 days

PK parameters - AUC0-∞

Timeframe: up to 18 days

PK parameters - Cmax

Timeframe: up to 18 days

PK parameters -tmax

Timeframe: up to 18 days

PK parameters -t½

Timeframe: up to 18 days

PK parameters -Vz/F

Timeframe: up to 18 days

PD parameters

Timeframe: up to 18 days

PK parameters - Ae0-t(urine)

Timeframe: up to 18 days

PK parameters - Ae0-t(feces)

Timeframe: up to 18 days